Thursday, November 20, 2014 6:15:24 PM
$ETRM..Key Info (DD) Post on Conf Call Today w/ key highlights into their PMA Approval for YE 14.
http://ir.enteromedics.com/eventdetail.cfm?EventID=152936
-"We are literally waiting for FDA Approval any day now." (1:30)
-Key Highlights
FDA Dialogue Has Specific Requests from it: (3:45 min mark-FDA Feedback)
*Company has been in continued active dialogue with the FDA. The FDA has asked the company 3 specific questions regarding their PMA.
(6:30 FDA Dialogue Questions)
#1) With Approval what would a post-approval registry look like.
#2) What would the ETRM labeling look like & how should it be worded.
#3) What Instructions for use of the Maestro should look like.
-Believe they have closed on all of the items the FDA has asked for and waiting for review to complete.
---------------------------------------------------------------
-Just hired a Chief Commercial Officer.
-Company already has CAT 3 codes. Will apply for CAT 1 code on approval.
Where will provider place the MAESTRO in the treatment paradigm (22m)
Looking for partners for distribution outside the U.S. & for exploring indications (24min)
Financing 26min. Largest batch or warrants are $2.19 or less. Expect for shareholders to exercise them on approval to lock in their financing. That way they won't have to do any additional dilution.
http://ir.enteromedics.com/eventdetail.cfm?EventID=152936
-"We are literally waiting for FDA Approval any day now." (1:30)
-Key Highlights
FDA Dialogue Has Specific Requests from it: (3:45 min mark-FDA Feedback)
*Company has been in continued active dialogue with the FDA. The FDA has asked the company 3 specific questions regarding their PMA.
(6:30 FDA Dialogue Questions)
#1) With Approval what would a post-approval registry look like.
#2) What would the ETRM labeling look like & how should it be worded.
#3) What Instructions for use of the Maestro should look like.
-Believe they have closed on all of the items the FDA has asked for and waiting for review to complete.
---------------------------------------------------------------
-Just hired a Chief Commercial Officer.
-Company already has CAT 3 codes. Will apply for CAT 1 code on approval.
Where will provider place the MAESTRO in the treatment paradigm (22m)
Looking for partners for distribution outside the U.S. & for exploring indications (24min)
Financing 26min. Largest batch or warrants are $2.19 or less. Expect for shareholders to exercise them on approval to lock in their financing. That way they won't have to do any additional dilution.
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